Coveram

Coveram

perindopril + amlodipine

Manufacturer:

Servier
Concise Prescribing Info
Contents
Perindopril arginine, amlodipine
Indications/Uses
Substitution therapy for treatment of essential HTN &/or stable CAD, in patients already controlled w/ perindopril & amlodipine given concurrently at the same dose level.
Dosage/Direction for Use
1 tab daily in the morning. If a change of posology is required, the dose could be modified or individual titration w/ free combination may be considered.
Administration
Should be taken on an empty stomach: Take before a meal.
Contraindications
Hypersensitivity to perindopril arginine, amlodipine or to any other ACE inhibitor, or to dihydropyridines derivatives. History of angioedema associated w/ previous ACE inhibitor therapy, hereditary or idiopathic angioedema. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²), severe hypotension, shock, including cardiogenic shock, obstruction of the outflow-tract of the left ventricle (eg, high grade aortic stenosis), unstable angina pectoris, heart failure after acute MI. Concomitant use w/ sacubitril/valsartan therapy, extracorporeal treatments leading to contact of blood w/ negatively charged surfaces, significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Not suitable for initial therapy. Stop treatment & monitor until complete resolution of symptoms in case of hypersensitivity/angioedema/intestinal angioedema. Angioedema associated w/ laryngeal oedema may be fatal. Combination w/ sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/valsartan must not be initiated until 36 hr after taking the last dose of perindopril therapy. Perindopril therapy must not be started until 36 hr after the last dose of sacubitril/valsartan. Concomitant use of ACE inhibitors w/ NEP inhibitors (eg, racecadotril), mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin) may lead to an increased risk of angioedema. Caution when starting racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin) in a patient already taking an ACE inhibitor. Temporarily w/hold treatment prior to exam in case of anaphylactoid reactions during low-density lipoproteins (LDL) apheresis. Temporarily w/hold treatment prior to exam in case of anaphylactoid reactions during desensitisation. Patients w/ collagen vascular disease, immunosuppressant therapy, treated w/ allopurinol or procainamide, periodic monitoring of white blood cell counts is advised. Increased risk of hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients w/ unilateral renal artery stenosis. Concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia & decreased renal function (including acute renal failure). Dual blockade of RAAS is not recommended. ACE inhibitors & angiotensin II receptor blockers should not be used concomitantly in patients w/ diabetic nephropathy. Not recommended in patients w/ primary hyperaldosteronism (not responding to drugs acting through inhibition of the renin-angiotensin system). Monitor BP in patients w/ hypotension. Renal function & K in patients at high risk of symptomatic hypotension (vol depleted or who have severe renin-dependent HTN) or w/ ischaemic heart or cerebrovascular disease. A transient hypotensive response is not a contraindication to further doses once the BP has increased after vol expansion. Aortic & mitral valve stenosis/hypertrophic cardiomyopathy. Patients w/ cardiac failure. Monitor K & creatinine in patients w/ renal impairment; individual dose titration w/ the monocomponents recommended if CrCl <60 mL/min. In patients w/ renal artery stenosis, blood urea & creatinine may increase; w/ renovascular hypertension, risk of severe hypotension & renal insufficiency. Amlodipine is not dialysable. Hepatic failure. Stop treatment in case of jaundice or marked elevations of hepatic enzymes. Slow dose titration & careful monitoring in severe hepatic impairment. Individual titration w/ the free combination of amlodipine & perindopril in patients w/ hepatic impairment. In Black patients, perindopril may be less effective & cause a higher rate of angioedema than in non-Black. Non-productive cough. Stop treatment 1 day prior to surgery. Frequent monitoring of blood K in renal insufficiency, worsening of renal function, age (>70 yr), DM, dehydration, acute cardiac decompensation, metabolic acidosis, & concomitant use of K-sparing diuretics, K supplement, K-containing salt substitutes & especially aldosterone antagonists or angiotensin-receptor blockers. Monitor glycaemia during 1st month in diabetic patients. Hypertensive crisis. Not to be taken in patients w/ galactose intolerance/glucose-galactose malabsorption/total lactase deficiency. Not suitable in patients w/ CrCl <60 mL/min. Stop treatment during pregnancy. Not to be used in childn & adolescents. Careful dosage increase in elderly.
Adverse Reactions
Oedema. Somnolence, dizziness, headache, dysgeusia, paraesthesia, vertigo, visual impairment, diplopia, tinnitus, palpitations, flushing, hypotension, dyspnea, cough, abdominal pain, nausea, vomiting, dyspepsia, change of bowel habit, diarrhoea, constipation, pruritus, rash, exanthema, joint swelling (ankle swelling), muscle spasms, fatigue, asthenia. Rhinitis, eosinophilia, hypersensitivity, hypoglycaemia, hyperkalaemia, hyponatraemia, insomnia, altered mood, anxiety, depression, sleep disorder, tremor, hypoaesthesia, syncope, tachycardia, arrhythmia (including bradycardia, ventricular tachycardia & atrial fibrillation), vasculitis, bronchospasm, dry mouth, angioedema of face, extremities, lips, mucous membranes, tongue, glottis &/or larynx, alopecia, purpura, skin discolouration, hyperhidrosis, urticaria, photosensitivity reactions, pemphigoid, arthralgia, myalgia, back pain, micturition disorders, nocturia, pollakiuria, renal failure, erectile dysfunction, gynaecomastia, peripheral oedema, chest pain, pain, malaise, pyrexia, increased or decreased wt, increased blood urea & creatinine, fall. Confusional state, psoriasis aggravation, increased blood bilirubin & hepatic enzyme. Leukopenia/neutropenia, agranulocytosis or pancytopenia, thrombocytopenia, haemolytic anaemia enzyme specific in patients w/ a congenital deficiency of G6PDH, hyperglycaemia, hypertonia, peripheral neuropathy, CVA possibly secondary to excessive hypotension in high-risk patients, angina pectoris, MI, eosinophilic pneumonia, gingival hyperplasia, pancreatitis, gastritis, hepatitis, jaundice, hepatitis either cytolytic or cholestatic, hepatic enzymes increased, Quincke’s oedema, erythema multiforme, SJS, exfoliative dermatitis, acute renal failure, decreased Hb & haematocrit. Extrapyramidal disorder (extrapyramidal syndrome), TEN & Raynaud’s phenomenon. SIADH can be considered as a very rare complication associated w/ ACE inhibitor therapy.
Drug Interactions
Contraindicated: Aliskiren in diabetic or impaired renal patients, extracorporeal treatments, sacubitril/valsartan. Not recommended: Aliskiren (in other patients), ARB, estramustine, co-trimoxazole, K-sparing diuretics (triamterene, amiloride), K salts, lithium, dantrolene (infusion). Special care: Antidiabetic agents (insulin, oral hypoglycaemic agents), non-K-sparing diuretics, K-sparing diuretics (eplerenone, spironolactone), racecadotril, mTOR inhibitors (sirolimus, everolimus, temsirolimus), NSAIDs including acetylsalicylic acid ≥3 g daily. Some care: gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin), sympathomimetics, gold. Requires special care: CYP3A4 inducers, CYP3A4 inhibitors, baclofen. To be taken into consideration: β-blockers, mTOR inhibitors, antihypertensive agents & vasodilatators, corticosteroids, tetracosactide, α-blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin), amifostine, TCAs, antipsychotics, anaesth. Drugs inducing hyperkalaemia: Aliskiren, K salts, K-sparing diuretics, ACE inhibitors, angiotensin-II receptors antagonists, NSAIDs, heparins, immunosuppressant agents eg, ciclosporin or tacrolimus, trimethoprim & co-trimoxazole (trimethoprim/sulfamethoxazole).
MIMS Class
Calcium Antagonists / ACE Inhibitors/Direct Renin Inhibitors
ATC Classification
C09BB04 - perindopril and amlodipine ; Belongs to the class of ACE inhibitors and calcium channel blockers. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Coveram 10 mg/10 mg tab
Packing/Price
30's (Rp444,700/pak)
Form
Coveram 10 mg/5 mg tab
Packing/Price
30's (Rp444,700/pak)
Form
Coveram 5 mg/10 mg tab
Packing/Price
30's (Rp349,350/pak)
Form
Coveram 5 mg/5 mg tab
Packing/Price
30's (Rp349,350/pak)
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